Patients Face Higher Costs and Less Innovation Due to FDA

CongerMartiDiskImplant2011-05-16.jpg“Marti Conger, a business consultant in Benicia, Calif., went to England in October 2009 to get an implant of a new artificial disk for her spine developed by Spinal Kinetics of Sunnyvale, Calif., a short distance from her home.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. B1) Late last year, Biosensors International, a medical device company, shut down its operation in Southern California, which had once housed 90 people, including the company’s top executives and researchers.

The reason, executives say, was that it would take too long to get its new cardiac stent approved by the Food and Drug Administration.
“It’s available all over the world, including Mexico and Canada, but not in the United States,” said the chief executive, Jeffrey B. Jump, an American who runs the company from Switzerland. “We decided, let’s spend our money in China, Brazil, India, Europe.”
. . .
(p. B7) “Ten years from now, we’ll all get on planes and fly somewhere to get treated,” said Jonathan MacQuitty, a Silicon Valley venture capitalist with Abingworth Management.
Marti Conger, a business consultant in Benicia, Calif., already has. She went to England in October 2009 to get an implant of a new artificial disk for her spine developed by Spinal Kinetics of Sunnyvale, Calif.
“Sunnyvale is 40 miles south of my house,” said Ms. Conger, who has become an advocate for faster device approvals in the United States. “I had to go to England to get my surgery.”
. . .
Device companies have been seeking early approval in Europe for years because it is easier. In Europe, a device must be shown to be safe, while in the United States it must also be shown to be effective in treating a disease or condition. And European approvals are handled by third parties, not a powerful central agency like the F.D.A.
But numerous device executives and venture capitalists said the F.D.A. has tightened regulatory oversight in the last couple of years. Not only does it take longer to get approval but it can take months or years to even begin a clinical trial necessary to gain approval.
Disc Dynamics made seven proposals over three years but could not get clearance from the F.D.A. to conduct a trial of its gel for spine repair, said David Stassen, managing partner of Split Rock Partners, a venture firm that backed the company. “It got to the point where the company just ran out of cash,” Mr. Stassen said. Disc Dynamics was shut down last year after an investment of about $65 million.

For the full story, see:
ANDREW POLLACK. “Medical Treatment, Out of Reach.” The New York Times (Thurs., February 10, 2011): B1 & B7.
(Note: ellipses added.)
(Note: the online version of the story is dated February 9, 2011.)

ArtificialDisk2011-05-16.jpg

“An artificial disk like the one Marti Conger received.”
Source of caption and photo: online version of the NYT article quoted and cited above.

Income Inequality Makes People Happy When It Gives Them Hope

(p. A19) If the royal family were to utilize Kate’s background to help encourage and spread this culture of entrepreneurship, the effects in Britain–and possibly much of the world–could be incredible. The people of the United Kingdom would be much richer, and not just in material terms. “Earned success gives people a sense of meaning about their lives,” writes the social scientist Arthur Brooks, who is president of the American Enterprise Institute think tank.

Indeed, studies show that in both the U.S. and U.K., many blue- and white-collar workers prefer to have the opportunity to advance, even if this means a less equal income distribution. A study of thousands of British employees by Andrew Clark, associate chair of the Paris School of Economics, found that measures of these workers’ happiness actually rose as their demographic group’s average income increased relative to their own.

These findings suggests that as people see members of their peer group gain wealth–even surpassing them–it gives them hope that they can improve their lot as well. As Mr. Clark put it in his study of British workers, “income inequality . . . need not be harmful for economic growth” if it “contains an aspect of opportunity.”

For the full story, see:
JOHN BERLAU. “The Entrepreneurs’ Princess; For centuries in Britain, commercial activities were looked down upon by the aristocracy, whose wealth lay in landownership.” Wall Street Journal (Thurs., APRIL 28, 2011): A17.

Socialism Is “Morally Corrupting”

On balance, Stephen Pollard believes that Claire Berlinski’s book on Thatcher is poorly written. But he does believe that Berlinski got one important point right:

(p. 22) She is quite right, . . . , to stress that Thatcher’s crusade against socialism was not merely about economic efficiency and prosperity but that above all, “it was that socialism itself — in all its incarnations, wherever and however it was applied — was morally corrupting.”

For the full review, see:
STEPHEN POLLARD. “Thatcher’s Legacy.” The New York Times Book Review (Sun., January 18, 2009): 22.
(Note: ellipsis added.)
(Norte: the online version of the review has the date January 16, 2009.)

Book reviewed:
Berlinski, Claire. There Is No Alternative: Why Margaret Thatcher Matters. New York: Basic Books, 2008.

Cars Bring Convenience, Freedom, and Personal Security

(p. 16) Two generations ago in the United States,most families lacked a car; by our parents’ generation, most families had one car while the two-car lifestyle was a much-sought ideal; today a third of America’s families own three cars or more. The United States now contains just shy of one automobile per licensed driver, and is on track to having more cars than licensed drivers. Cars are a mixed blessing, as a future chapter will detail: But there is no doubt they represent convenience, freedom, and, for women, personal security, when compared to standing on street corners waiting for buses or lingering on dark subway platforms. Cars would not he so infuriatingly popular if the did not make our lives easier. Today all but the bottom-most fraction of the impoverished in the United States do most of their routine traveling by car: 100 auto trips in the United States for every one trip on a bus or the subway, according to the American Public Transit Association. The portion of routine trips made in private cars is rising toward overwhelming in the European Union, too. Two generations ago, people dreamed of possessing their own cars. Now almost everyone in the Western world who desires a car has one–and vehicles that are more comfortable, better-equipped, lower-polluting, and much safer than those available only a short time ago.

Source:
Easterbrook, Gregg. The Progress Paradox: How Life Gets Better While People Feel Worse. Paperback ed. New York: Random House, 2004.

Scots Fear London May Delay the Dawn

InvernessScotlandDarkDawn2011-03-09.jpg

“Inverness, Scotland, at 8 a.m. Thursday. A change to year-round daylight time in Britain would make winter sunrise as late as 10 a.m. in the north.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. A7) INVERNESS, Scotland — The question was time, and whether to support legislative efforts in London to move it around in order to bring more light to the afternoons. The answer was no, said Jean Kaka, 67, a resident of this city far to the north.
. . .
“They’re trying to tamper with our time,” she said. “England is a different country than we are, and they’re imposing this on us.”
. . .
The problem is that while a clock change might bring afternoon joy to London, it would condemn Inverness in the far reaches of Scotland — in relative terms, about 700 miles north of Montreal — to long, dark winter mornings with sunrises as late as 10 a.m.
Even worse, many Scots feel, it would mean giving in to English politicians. Though the devolution of British politics has given Scotland its own legislature and responsibility for many of its own affairs, the clock is still controlled by Parliament in London.
“Certainly the people in London don’t have any real concept of the effects further north,” said Anthony Billington, 64, who was strolling through town recently. “I’m much more of a morning person, anyway.”
. . .
Robin MacDonald, 63, who owns a television store in downtown Inverness, said that while Parliament’s efforts to jump time ahead hardly mean that time is literally being stolen from him, he could do without having to set and reset his clocks twice a year.
When he was a child in the rural north, he said, he traveled to and from school in conditions “as dark as the inside of your hat.” So he doesn’t care what time legislators decide it is, as long as they decide something.
“They should make up their mind,” Mr. MacDonald said, “and then they should leave it alone.”

For the full story, see:

SARAH LYALL. “Inverness Journal; Scots Tell London, Hands Off Our Clocks.” The New York Times (Fri., January 21, 2011): A7.

(Note: ellipses added.)
(Note: the online version of the article is dated January 20, 2011.)

MacDonaldRobinAndClock2011-03-09.jpg “Robin MacDonald would rather not have to reset his clocks twice a year.” Source of caption and photo: online version of the NYT article quoted and cited above.

“The Adventurous, Pioneering Spirit”

Jet_AgeBK.jpeg

Source of book image: http://www.jetagebook.com/

(p. 30) “Jet Age” is ostensibly about the race between two companies and nations to commercialize a military technology and define a new era of air travel. There’s Boeing with its back to the wall and its military contracts drying up, betting everything on passenger jets, pitted against de Havilland and the government-subsidized project meant to reclaim some of Britain’s lost glory. . . .
. . .
But the book is really about the risk-taking essential for making any extreme endeavor common­place. “Jet Age” celebrates the managers, pilots, engineers, flight attendants and, yes, even passengers (for without passengers there is no business) who gambled everything so that we might cross oceans and continents in hours rather than days.
It is easy to forget, in this time of overcrowded flights, demoralizing security checks, embattled flight attendants and dwindling service, that risk was once embraced as a necessary, even desirable, part of flying. Quoted in the book, the celebrated aviator Lord Brabazon summed it up in post-accident testimony: “You know, and I know, the cause of this accident. It is due to the adventurous, pioneering spirit of our race. It has been like that in the past, it is like that in the present, and I hope it will be in the future.”

For the full review, see:
MICHAEL BELFIORE. “Fatal Flaws.” The New York Times Book Review (Sun., February 6, 2011): 30.
(Note: ellipses added.)
(Note: the online version of the article is dated February 4, 2011.)

The book under review is:
Verhovek, Sam Howe. Jet Age: The Comet, the 707, and the Race to Shrink the World. New York: Avery, 2010.

Luddism in 1811 England

(p. 243) The stockingers began in the town of Arnold, where weaving frames were being used to make cut-ups and, even worse, were being operated by weavers who had not yet completed the seven-year apprenticeship that the law required. They moved next to Nottingham and the weaver-heavy villages surrounding it, attacking virtually every night for weeks, a few dozen men carrying torches and using prybars and hammers to turn wooden frames–and any doors, walls, or windows that surrounded them–into kindling. None of the perpetrators were arrested, much less convicted and punished.

The attacks continued throughout the spring of’ 1811, and after a brief summertime lull started up again in the fall, by which time nearly one thousand weaving frames had been destroyed (out of the 25.000 to 29,000 then in Nottingham, Leicestershire, and Derbyshire), resulting in damages of between £6,000 and £10.000. That November, a commander using the nom de sabotage of Ned Ludd (sometimes Lud)–the name was supposedly derived from an apprentice to a Leicester stockinger named Ned Ludham whose reaction to a reprimand was to hammer the nearest stocking frame to splinters–led a series of increasingly daring attacks throughout the Midlands. On November 13, a letter to the Home Office demanded action against the “2000 men, many of them armed, [who] were riotously traversing the County of Nottingham.”
By December 1811, rioters appeared in the cotton manufacturing capital of Manchester, where Luddites smashed both weaving and spinning machinery. Because Manchester was further down the path to industrialization, and therefore housed such machines in large factories as opposed to small shops, the destruction demanded larger, and better organized, mobs.

Source:
Rosen, William. The Most Powerful Idea in the World: A Story of Steam, Industry, and Invention. New York: Random House, 2010.
(Note: italics and bracketed word in original.)

Carlyle (and Rosen) on Arkwright

(p. 236) The greatest hero-worshipper of them all, Thomas Carlyle. described Arkwright as

A plain, almost gross, bag-checked, potbellied, much enduring, much inventing man and barber… . French Revolutions were a-brewing: to resist the same in any measure, imperial Kaisers were impotent without the cotton and cloth of England, and it was this man that had to give England the power of cotton…. It is said ideas produce revolutions, and truly they do; not spiritual ideas only, but even mechanical. In this clanging clashing universal Sword-dance which the European world now dances for the last half-century, Voltaire is but one choragus [leader of a movement, from the old Greek word for the sponsor of a chorus] where Richard Arkwright is another.

. . .
Arkwright was not a great inven-(p. 237)tor, but he was a visionary, who saw, better than any man alive, how to convert useful knowledge into cotton apparel and ultimately into wealth: for himself, and for Britain.

Source:
Rosen, William. The Most Powerful Idea in the World: A Story of Steam, Industry, and Invention. New York: Random House, 2010.
(Note: internal ellipses in original; ellipsis between paragraphs added.)

REVISE THIS ONE: Patents Needed to Provide Money for “the Many Fruitless Experiments”

(p. 234) . . . ; together, Watt and Arkwright wrote a manuscript entitled “Heads of a Bill to explain and amend the laws relative to Letters Patent and grants of privileges for new inventions,” essentially a reworking of Coke’s Statute of 1623 that had created England’s first patent law. In addition to its policy prescriptions, which were largely an unsuccessful argument against the requirement that patent applications be (p. 235) as specific as possible, the manuscript offered a remarkable insight into Watt’s perspective on the life of the inventor, who should, in Watt’s own (perhaps inadvertently revealing) words, “be considered an Infant, who cannot guard his own Rights”:

An engineer’s life without patent is not worthwhile . . . few men of ingenuity make fortunes without suffering to think seriously whether the article he manufactures might, or might not, be Improved. The man of ingenuity in order to succeed must seclude himself from Society, he must devote the whole powers of his mind to that one object, he must persevere in spite of the many fruitless experiments he makes, and he must apply money to the expenses of these experiments, which strict Prudence would dedicate to other purposes. By seclusion from the world he becomes ignorant of its manners, and unable to grapple with the more artful tradesman, who has applied the powers of his mind, not to the improvement of the commodity he deals in, but to the means of buying cheap and selling dear, or to the still less laudable purpose of oppressing such ingenious workmen as their ill fate may have thrown into his power.

Source:
Rosen, William. The Most Powerful Idea in the World: A Story of Steam, Industry, and Invention. New York: Random House, 2010.
(Note: the second ellipsis and the italics in original; the first ellipsis added.)

“A Nation’s Heroes Reveal Its Ideals”

(p. 133) Robert and John Hart were two Glasgow engineers and merchants who regarded James Watt with the sort of awe usually reserved for pop musicians, film stars, or star athletes. Or even more: They regarded him as “the greatest and most useful man who ever lived.” . . .
. . .
(p. 134) . . . the hero worship of the brothers Hart is more enlightening about the explosion of inventive activity that started in eighteenth-century Britain than their reminiscences. For virtually all of human history, statues had been built to honor kings, solders, and religious figures; the Harts lived in the first era that built them to honor builders and inventors. James Watt was an inventor inspired in every way possible, right down to the neurons in his Scottish skull; but he was also, and just as significantly, the inspiration for thousands of other inventors, during his lifetime and beyond. The inscription on the statue of Watt that stood in Westminster Abbey from 1825 until it was moved in 1960 reminded visitors that it was made “Not to perpetuate a name which must endure while the peaceful arts flourish, but to shew that mankind have learned to know those who best deserve their gratitude” (emphasis added).
A nation’s heroes reveal its ideals, and the Watt memorial carries an impressive weight of symbolism. However, it must be said that the statue, sculpted by Sir Francis Chantrey in marble, might bear that weight more appropriately if it had been made out of the trademark material of the Industrial Revolution: iron.

Source:
Rosen, William. The Most Powerful Idea in the World: A Story of Steam, Industry, and Invention. New York: Random House, 2010.
(Note: ellipses added; italics in original.)

Coke’s Patent Law Motivated by Belief that Creative Craftsmen Were Source of Britain’s Prosperity

William Rosen discusses the genesis and significance of the world’s first patent law:

(p. 52) The Statute became law in 1624. The immediate impact was barely noticeable, like a pebble rolling down a gradual slope at the top of a snow-covered mountain. For decades, fewer than six patents were awarded annually, though still more in Britain than anywhere else. It was seventy-five years after the Statute was first drafted, on Monday, July 25, 1698, before an anonymous clerk in the employ of the Great Seal Patent Office on Southampton Row, three blocks from the present–day site of the British Museum, granted patent number 356: Thomas Savery’s “new Invention for Raiseing of Water and occasioning Motion to all Sorts of Mill Work by the lmpellent Force of Fire.”

Both the case law and the legislation under which the application was granted had been written by Edward Coke. Both were imperfect, as indeed was Savery’s own engine. The law was vague enough (and Savery’s grant wide-ranging enough; it essentially covered all ways for “Raiseing of Water” by fire) that Thomas Newcomen was compelled to form a partnership with a man whose machine scarcely resembled his own. But it is not too much to claim that Coke’s pen had as decisive an impact on the evolution of steam power as any of Newcomen’s tools. Though he spent most of his life as something of a sycophant to Elizabeth and James, Coke’s philosophical and temperamental affinity for ordinary Englishmen, particularly the nation’s artisans, compelled him to act, time and again, in their interests even when, as with his advocacy of the 1628 Petition of Right (an inspiration for the U.S. Bill of Rights) it landed him in the King’s prisons. He became the greatest advocate for England’s craftsmen, secure in the belief that they, not her landed gentry or her merchants, were the nation’s source of prosperity. By understanding that it was England’s duty, and–perhaps even more important–in England’s interest, to promote the creative labors of her creative laborers, he anticipated an economic philosophy far more modern than he probably understood, and if he grew rich in the service of the nation, he also, with his creation of the world’s first durable patent law, returned the favor.

Source:
Rosen, William. The Most Powerful Idea in the World: A Story of Steam, Industry, and Invention. New York: Random House, 2010.
(Note: italics in original.)